This circular identifies and updates the Department's policies with respect to the review and clearance of collections of information, as encompassed by the Paperwork Reduction Act (PRA) of 1995.

Direct questions, comments, suggestions, or requests for further information to Mr. Robert Polson, Office of Information Resources Management (OIRM), at (202) 690-6741; send e-mail to Robert.Polson@hhs.gov; or visit our web site at URL: www.hhs.gov/oirm/infocollect.

Key Points Covered in this Circular

• Identifies fundamental features of the Paperwork Reduction Act relating to information collection.
• Identifies responsibilities delegated to the Department and to the Operating Divisions.
• Provides instructions for preparing the "Paperwork Reduction Act Submission" (form OMB 83-1).
• Provides instructions for preparing the Supporting Statement.

1. Paperwork Reduction Act of 1995

   The Paperwork Reduction Act (PRA) of 1995 ("the Act," Public Law [PL] 10413) revises the PRA of 1980 (PL 96-511) as amended by the Paperwork Reduction Reauthorization Act of 1986 (PL 99-500).

   The fundamental features of the Act relating to information collection are that an agency shall not conduct or sponsor the collection of information unless, in advance of the adoption or revision of the collection of information:

   1. the agency has:
      • conducted a review to evaluate independently and fairly whether proposed collections of information should be approved;

      • evaluated public comments received after providing appropriate notice in the Federal Register and consulted with members of the public and affected agencies;

      • submitted to the Office of Management and Budget (OMB), as part of the clearance request, certifications that the proposed collections are necessary for the proper performance of agency functions; are not duplicative of other accessible information; reduce burden to the extent practicable; are written in plain terminology; are consistent and compatible with existing reporting practices; indicate how long records must be maintained; explain the nature and purposes of the collection; have been developed in an efficient and effective manner; use appropriate statistical survey methodology; and use information technology to reduce burden and improve quality;

      • published a 30-day Federal Register notice at the time of the submission of the clearance request to OMB;

   2. OMB has approved the proposed collection of information; and

   3. the agency has received a control number and an expiration date to be displayed with the collection of information.

   On August 29, 1995, OMB published a regulation, "Controlling Paperwork Burdens on the Public; Regulatory Changes Reflecting Recodification of the Paperwork Reduction Act," (5 CFR Part 1320) that implements the provisions of the Act.

   The Act and the OMB regulation make agency responsibilities more explicit for developing proposed collections of information and submitting them to OMB for review and approval. Agency responsibilities include the following.

   • Independent review: requires a paperwork review process "sufficiently independent of program responsibility"; in order to meet this requirement, all requests for OMB clearance must be cleared at the Departmental level prior to submittal to OMB.

   • Need to develop new collections of information carefully: requires the Department to evaluate the need for each aspect of the information collection, estimate respondent burdens, and pilot-test the collection (where appropriate).

   • Informing the respondent: requires the Department to inform respondents of the reasons for the collection; how the information will be used; estimate burden; whether responses are voluntary, mandatory, or required for a benefit; and the necessity of a valid OMB control number.

   • Seeking public comment: requires the Department to solicit comments through Federal Register notices. Requirements for public comment will vary depending on whether the information requirements are contained in current rules, proposed rules, or not in rules (see Departmental Procedures for Review of Information Collection Requests, provided in Appendix A).

   • Certification to OMB: requires the Department to certify that the collection meets certain standards.

   • Federal Register notice: requires the Department to provide copies of the Federal Register notice(s).

   • Planning for enough time: requires the Department to allow sufficient time for public comment prior to submittal to OMB (at least 60 days) and for OMB review (from 30 to 60 days).

   In September 1995, the Office of Information and Regulatory Affairs of OMB issued a memorandum on "Revised OMB 83 Forms Series to implement the PRA of 1995." The memorandum introduced the new form, OMB 83-I, which superseded the old form as of October 1995.

   In February 1997, OIRA published The PRA of 1995: Implementing Guidance, Preliminary Draft. The Guidance contains:

   • an explanation of the Act and its scope, including types of information collection covered, what collections are exempt and what items are generally considered not to be information;

   • statements as to how the public is protected by the Act and how the public becomes involved;

   • criteria for OMB approval and the clearance process for OMB approval;

   • internal agency review and agency action to demonstrate proper preparation; internal agency evaluation of an information collection; and how an agency is able to approve its own collection of information; and

   • various appendices containing copies of documents and answers to frequently asked statistical questions.

2. HHS Delegation of Authority and Procedures

   This circular revises and supersedes the redelegations of authority and revised Departmental procedures concerning information collection clearance ("reports clearance") issued in January 1989 by the Assistant Secretary for Management and Budget and reissued in November 1991.

This circular applies to all HHS organizations. Within the circular, the term OPDIV includes the HHS OPDIVs as well as the Office of the Secretary as a combined, single entity. The Office of the Secretary includes the Regional Directors.

The Department will continue to comply fully with the requirements of 5 CFR 1320, which implements the provisions of the PRA of 1995 regarding agency review of information collections as well as OMB review and clearance of information collections. OPDIVs shall follow the procedures contained in Attachment A, Departmental Procedures for Review of Information Collection Requests.

The Deputy Assistant Secretary for Information Resources Management (DASIRM), under the authority delegated by the ASMB, shall:

• ensure the Department compliance and conformance with OMB regulations, policies, standards, procedures, and instructions concerning agency reviews, paperwork reduction and OMB clearance of collections of information;

• develop Departmental information collection policy and the Department's Information Collection Budget, and monitor OPDIV management of information collection burden on the public;

• conduct a review process for proposed information collections, "sufficiently independent of program responsibility to evaluate fairly whether proposed collections of information should be approved" by OMB; and

• certify that the proposed information collections meet all PRA requirements and send them to OMB for review, or send the request packages back to the OPDIV to resolve issues or for reconsideration or other appropriate action.

The OPDIVs, under the authority delegated by the ASMB, shall:

• ensure compliance with OMB and Departmental regulations, policies, standards, procedures and instructions with regard to clearance of collections of information;

• plan for the development of new collections of information and the extension of ongoing collections well in advance to allow for public comment, Departmental certification and OMB review;

• conduct independent reviews of proposed information collections;

• prepare and submit to the Department their information collection clearance request packages for submission to OMB;

• provide the Department with certification that the proposed collection of information meets the standards set forth in the Act;

• produce and approve notices for publication in the Federal Register;

• manage the OPDIV burden reduction program; and

• develop and manage their Information Collection Budget.

Burden
Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency, including:

• reviewing instructions;

• developing, acquiring, installing, and utilizing technology and systems for the purpose of collecting, validating, and verifying nformation;

• developing, acquiring, installing and utilizing technology and systems for the purpose of disclosing and providing information;

• adjusting the existing ways to comply with any previously applicable instructions and requirements;

• training personnel to be able to respond to a collection of information;

• searching data sources;

• completing and reviewing the collection of information;

• transmitting or otherwise disclosing the information.

Collection of information
Collections of information means the obtaining, causing to be obtained, soliciting, or requiring the disclosure to an agency, third parties or the public of information by or for an agency by means of identical questions posed to, or identical reporting, recordkeeping, or disclosure requirements imposed on ten or more persons, whether such collection of information is mandatory, voluntary, or required to obtain or retain a benefit. The term includes questions posed to agencies, instrumentalities, or employees of the United States, if the results are to be used for general statistical purposes. However, the definition excludes targeted investigations and audits.

Control number
Control number is the number assigned by OMB to a collection of information denoting that OMB has approved of the collection.

Information collection budget
Information Collection Budget is a management tool used by OMB and agency officials to measure and control the costs and burden of Federal information collections.

Person
Person means, for the purposes of the control of paperwork burdens on the public, an individual, partnership, association, corporation (including government owned but contractor operated facilities), business trust, legal representative, organized group of individuals, State, territory, or local government or component thereof. The term excludes current employees of the Federal government for purposes of obtaining information about and within the scope of their employment.

The PRA of 1995, Public Law 10413.

5 CFR 1320, Controlling Paperwork Burdens on the Public, (as revised in 60 F.R. 44978, August 25, 1995).

The PRA of 1995: Implementing Guidance, Preliminary Draft, Office of Management and Budget, Office of Information and Regulatory Affairs, February 1997.

Any OPDIV or STAFFDIV experiencing difficulty interpreting or implementing IRM policy guidance issued through the IRM Circular Series is urged to contact OIRM for assistance. Information and assistance may be obtained by contacting the Office of Policy and Evaluation, OIRM, Office of the Assistant Secretary for Management and Budget, Department of Health and Human Services, Washington, D.C. 20201, telephone (202) 690-5515.